| TGA Action ID |
RC-2025-RN-00423-1 |
| Type of Product |
Medicine |
| Product Name/Description |
18F-Flurodeoxy Glucose (18F-FDG) for injection
Batch: FDG250411A
Expiry 11/04/2025
ARTG Exempt |
| ARTG Number |
|
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
The affected batch of 18F-FDG returned a positive result on the retrospective sterility test and therefore does not comply with the requirements of a sterile pharmaceutical for injection. The organism identified in the failed sterility test was Bacillus infantis.
Patients administered with this batch of 18F-FDG on the 11th of April 2025 would theoretically be at a risk of developing an infection.
Given the nature of the product, this action was undertaken prior to TGA notification (Immediate Market Action as defined within the (PRAC). |
| Instructions for Customers/Users |
All product was administered at the point of notification. Customers are to review all injected patients inline with the below specialist advice provided by the Sponsor:
If a patient with a prosthetic devices i.e. valve, joint or lines that are longstanding or immunosuppressed to look out for a febrile illness. If it occurs the patient is to be reviewed by their GP. Secondary infection is unlikely but possible in these groups.
Customers are to notify the sponsor if any notable adverse events following administration were recorded for patients injected with the affected batch of 18F-FDG on the 11/04/2025.
This action has been closed out on 07/11/2025. |
| Action Commencement Date |
7/05/2025 |
| Responsible Entity |
|
| Contact Information |
07 3646 3055 - Metro North Hospital and Health Service |